Senior Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead the planning and execution of clinical data management activities for global development initiatives.

• Develop and supervise data management strategies and plans.

• Create data capture tools and oversee data processing, coding, validation, and continuous data quality monitoring.

• Establish and maintain clinical data systems and infrastructure.

• Identify, set up, test, and provide technical oversight for EDC, IRT, ePRO, ECG, and other external data technologies.

• Drive the strategy for data standards and ensure compliance, including adherence to CDISC/CDASH standards.

• Collaborate with internal stakeholders, external CROs, and technology vendors regarding requirements, timelines, deliverables, and performance metrics.

• Oversee vendor technology platforms and processes to ensure regulatory, quality, and inspection readiness.

• Develop and manage data management documentation, including data management plans and data transfer plans.

• Create validated automated data flows for both internal and external data.

• Monitor timelines, milestones, and deliverables; communicate risks, metrics, and status updates.

• Generate and review in-process data reports and listings for trial oversight, safety, and data review.

• Provide data management insights for protocols, protocol amendments, clinical study reports, and statistical analysis plans.

• Ensure data integrity, quality, regulatory compliance, and readiness for GCP inspections.

• Contribute to the establishment of best practices, SOPs, and scalable data management processes.

⛳️ Requirements

• Bachelor’s or Master’s degree.

• A minimum of 6+ years of practical clinical data management experience within a pharmaceutical or biotechnology environment.

• Authorized to work full-time in the United States; Lilly will not provide work authorization or visa sponsorship.

• Expert knowledge of electronic clinical data systems, including various vendor EDC platforms and related clinical trial technologies.

• Proven experience in managing and collaborating with CROs and technical vendors, including oversight of deliverables, timelines, and quality assurance.

• Strong understanding of regulatory requirements affecting clinical data management.

• Experience supporting regulatory submissions.

• Demonstrated experience in supporting multiple complex clinical studies, including early-phase first-in-human and proof-of-concept trials.

• Excellent project planning and organizational skills.

• Ability to prioritize competing demands, manage timelines, and produce high-quality work in a fast-paced environment.

• Strong analytical skills, intellectual curiosity, and a proactive approach to problem-solving.

• Exceptional interpersonal, communication, and presentation skills.

• Ability to effectively influence and collaborate across cross-functional teams and with external partners.

• Strong critical thinking and strategic analysis abilities.

• Experience with Phase I–III studies is preferred.

• Experience in CNS, oncology, and/or rare disease indications is advantageous.

• Pre-IND, IND, NDA, and/or BLA experience is highly preferred.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Prescription drug benefits.

• Healthcare flexible spending accounts.

• Dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Employee assistance program.

• Fitness benefits.

• Employee clubs and activities.

• Occasional travel opportunities.